Effects of Anesthesia Techniques on Tissue Oxygenation and Recovery in Lower Abdominal Surgery

NCT ID: NCT07102108

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-01

Brief Summary

This is a prospective observational study designed to evaluate the effects of different anesthesia techniques on tissue oxygenation and postoperative recovery in patients undergoing lower abdominal surgery. A total of 180 patients will be enrolled and evenly allocated into four groups based on the anesthesia method used: general anesthesia, spinal anesthesia, epidural anesthesia, and combined general plus epidural anesthesia.

Near-infrared spectroscopy (NIRS) will be utilised to monitor tissue oxygenation at the thenar and plantar regions during the perioperative period. Vital signs, VAS scores(min 0-max 10 points), Quality of Recovery-40 (QoR-40) scores(min 40-max 200 points), and additional postoperative recovery parameters- including length of stay in the post-anesthesia care unit and hospital, surgical site infection, wound revision, and mortality- will be recorded and compared across the groups.

The primary hypothesis is that regional anesthesia techniques enchance tissue oxygenation and are associated with improved postoperative recovery outcomes compared to general anesthesia alone. The study was approved by the local ethics committee and will be conducted at a single tertiary-care center.

Conditions

Lower Abdominal Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

General Anesthesia

Patient receiving general anesthesia only for lower abdominal surgery

No interventions assigned to this group

General+Epidural Anesthesia

Patient receiving combined general and epidural anesthesia for lower abdominal surgery

No interventions assigned to this group

Spinal

Patient receiving spinal anesthesia only for lower abdominal surgery

No interventions assigned to this group

Epidural Anesthesia

Patient receiving epidural anesthesia only for lower abdominal surgery

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults aged 18-80 years
• Scheduled for elective lower abdominal surgery
• Eligible for general, spinal, epidural or combined anesthesia techniques
• Provided writen informed consent
• ASA physical status 1-3

Exclusion Criteria

• Refusal to participate
• Emergency surgery
• Severe cardiovascular or respiratory instability
• Pre-existing severe cognitive impairment of communication barrier
• Peripheral vascular disease affecting NIRS readind
• Local infection or anatomical anomaly preventing regional anesthesia

• Minimum Eligible Age: 18 Days
• Maximum Eligible Age: 80 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Ars Gor Dr Edip Gules

Research Assistant-Anestesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Trakya University, Faculty of Medicine

Edirne, Central, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TUTF-GOBAEK 2023-25

Identifier Type: OTHER

Identifier Source: secondary_id

TUTF-GOBAEK 2023-25

Identifier Type: -

Identifier Source: org_study_id